Senior Manager EDC Development
New
IndiaFull-TimeManager
Salary not disclosed
Apply NowOpens the employer's application page
Job Details
- Experience
- 8+ years of experience in biotechnology, pharmaceutical, or healthcare industries; 4+ years of hands-on EDC development; 3+ years of people management.
- Required Skills
- People Management
Requirements
- Bachelor’s degree in mathematics, science, information systems, or a related field (advanced degree preferred).
- 8+ years of experience in biotechnology, pharmaceutical, or healthcare industries.
- At least 4+ years of hands-on EDC development experience in regulated environments.
- Minimum 3+ years of people management experience leading technical or operational teams.
- Strong expertise in Medidata Rave, including database design, edit check programming, and administration.
- Deep understanding of UAT methodologies, QC processes, and clinical data standards.
- Knowledge of regulatory frameworks such as 21 CFR Part 11, ICH-GCP, and CDISC standards.
- Proven experience managing CRO/vendor relationships and ensuring high-quality deliverables.
- Strong leadership, strategic thinking, and stakeholder management skills in matrix environments.
- Ability to influence senior stakeholders and drive cross-functional alignment.
- Exposure to tools such as Medidata Builder, TrialGrid, or programming languages (e.g., C#) is a plus.
Responsibilities
- Lead and develop teams of managers and specialists across EDC Development, UAT, and Quality Control functions, including performance management and career growth.
- Oversee resource planning, workload distribution, and capacity management across global clinical trial portfolios.
- Drive end-to-end EDC database development including eCRF design, database build, edit check programming, and post-production updates.
- Manage UAT planning and execution, including defect resolution, testing validation, and release readiness assessments.
- Establish and enforce UAT standards, templates, and quality frameworks to ensure consistency across systems and vendors.
- Partner with CROs and cross-functional stakeholders to ensure alignment on EDC strategy and delivery quality.
- Lead innovation initiatives by evaluating and implementing new EDC technologies, tools, and automation solutions.
- Develop and maintain SOPs, governance models, and continuous improvement processes across EDC and UAT functions.
- Act as escalation point for complex technical, operational, and stakeholder management issues.
View Full Description & ApplyYou'll be redirected to the employer's site
